3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H

K173437 · 3M Company · FRC · Mar 19, 2018 · General Hospital

Device Facts

• Record ID: K173437
• Device Name: 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Mar 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with both the 3M™ Attest™ Auto-reader 490 or the Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of: - 3 minutes at 270°F (132°C) - 4 minutes at 270°F (132°C) - 3 minutes at 275°F (135°C)

Device Story

System consists of 3M Attest 1492V biological indicator (BI) and 490/490H auto-readers. BI is a single-use polycarbonate sleeve containing Geobacillus stearothermophilus spores and media ampoule. After sterilization, BI is placed in auto-reader; reader incubates at 60°C and monitors for fluorescence using UV LED, optical filters, and photodiode. Fluorescence indicates sterilization failure. Auto-reader provides visual/audible alerts and stores 100 most recent results. Used in clinical settings to verify steam sterilization efficacy. Software version 4.0.0+ enables 24-minute rapid readout. Benefits include rapid confirmation of sterilization cycle performance, allowing faster release of sterilized instruments.

Clinical Evidence

No clinical data included. Bench testing only. Performance verified against ISO 11138-1:2017 and ISO 11138-3:2017 standards. Testing confirmed >97% alignment with 7-day conventional incubation, successful positive controls, kill/survival time windows, D-value requirements, and maintenance of 60°C incubation temperature.

Technological Characteristics

Polycarbonate sleeve BI with polypropylene carrier; Geobacillus stearothermophilus spores. Sensing via UV LED, optical filters, and photodiode. Energy source: 100-240V AC. Connectivity: Ethernet for remote status viewing. Software version 4.0.0+; incubation at 60 ± 2°C. Safety compliance: IEC 61010-1, IEC 61010-2-010.

Indications for Use

Indicated for use by healthcare personnel to qualify or monitor dynamic-air-removal steam sterilization cycles at 132°C and 135°C using the 3M Attest 1492V biological indicator and 490/490H auto-readers.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

• 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V and 3M™ Attest™ Auto-reader 490 (K121484)

Reference Devices

• 3M™ Attest™ Auto-reader 490H (K171003)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 19, 2018

3M Health Care Ms. Hilary B. Hovde Regulatory Affairs Associate 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

Re: K173437

Trade/Device Name: 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V 3MTM Attest™ Auto-reader 490 3MTM Attest™ Auto-reader 490H Regulation Number: 21 CFR 880.2800 Biological Sterilization Process Indicator Regulation Name: Regulatory Class: Class II Product Code: FRC Dated: February 12, 2018 Received: February 14, 2018

Dear Hilary B. Hovde:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173437

Device Name

3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H

#### Indications for Use (Describe)

Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with both the 3M™ Attest™ Auto-reader 490 or the Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of:

- · 3 minutes at 270°F (132°C)
- · 4 minutes at 270°F (132°C)
- · 3 minutes at 275°F (135°C)

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary for 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V, 3MTM Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

> Contact: Hilary B. Hovde Regulatory Affairs Associate Phone Number: [phone] FAX Number: [phone]

Submission Date: March 16, 2018

K173437

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#### Device Name and Classification:

| Common or Usual Name: | Biological Indicator |
|------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V<br>3M™ Attest™ Auto-reader 490<br>3M™ Attest™ Auto-reader 490H |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR § 880.2800(a)) |
| Device Classification: | Class II |
| Product Code: | FRC |

## Predicate Device:

- 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V and 3MTM Attest™ Auto-reader 490, K121484
#### Reference Device:

- 3MTM Attest™ Auto-reader 490H, K171003 . (490 Auto-reader will be shown to be identical to the 490H Auto-reader)
## Indications for Use

Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with both the 3M™ Attest™ Auto-reader 490 or the Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of:

- 3 minutes at 270°F (132°C) .
- 4 minutes at 270°F (132°C) ●
- 3 minutes at 275°F (135°C) .

## Description of Device:

The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater) to qualify or routinely challenge dynamic-air-removal steam sterilization cycles at 132°C and 135°C.

The 1492V BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1492V BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of the 1492V BI in the 490 Auto-reader or the 490H Auto-reader (software version 4.0.0 or greater) indicates a sterilization failure.

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## Nonclinical Comparison to the Predicate Device

This submission is addressing an expansion to the indications for use to include qualifying or monitoring dynamic-air-removal steam sterilization cycles of 3 minutes at 270°F (132°C), a software change to the 3M™ Attest™ Auto-reader 490 to reduce the final fluorescent readout for the 1492V BI from 1 hour to 24 minutes, and to change the incubation temperature from 56°C to 60°C. The Model 490 Auto-reader is now identical to the Model 490H Auto-reader (software version 4.0.0 or greater) as it incubates at the same temperature and uses the same software. The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is the same design as the previously cleared device of the same model number. The device has the same materials and fundamental scientific technology.

#### Summary of Nonclinical Testing

Testing was conducted on the biological indicator following the FDA guidance and the standards below:

- . Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- . ISO 11138-1:2017 Sterilization of health care products – Biological indicators, Part 1: General Requirements
- ISO 11138-3:2017 Sterilization of health care products Biological indicators, Part 3: ● Biological indicators for moist heat sterilization processes
- ANSI/AAMI/ISO 18472:2006 (R)2015 Sterilization of Health Care Products ● Biological and Chemical Indicators: Test Equipment
- United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization and Chapter <55> Biological Indicators - Resistance Performance Tests

The effectiveness of the 3M™ Super Attest™ Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ Auto-reader 490 with a final fluorescent readout of 24 minutes and an incubation temperature of 60°C (i.e., identical to the Model 490H Auto-reader having software version 4.0.0 or greater) is demonstrated in the following tests:

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| Test | Results |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Positive Control | Passed |
| Survival Time = Calculated survival time* or 1 minute at 132°C and 40 seconds at 135°C, whichever is longer | Passed<br>132°C ≥ 2.07 minutes<br>135°C ≥ 1.82 minutes |
| Kill Time = Calculated kill time* at 132°C and at 135°C<br>* ISO 11138-1:2017, Annex E | Passed<br>132°C ≤ 5.07 minutes<br>135°C ≤ 4.45 minutes |
| Reduced Incubation Time<br>Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout times:<br>• Fluorescent result in 24 minutes<br>• Optional visual pH color change result in 48 hours | Passed |
| D-Value<br>Greater than or equal to 10 seconds at 132°C<br>Greater than or equal to 8 seconds at 135°C | Passed<br>D132°C ≥ 24 seconds<br>D135°C ≥ 21 seconds |
| Population (Total Viable Spore Count)<br>Greater than or equal to 106 spores | Passed |
| Component Inhibition Studies<br>Components have no impact on the recovery of 10-100 organisms | Passed |
| Hold Time Assessment<br>D-value does not change when activated 7 days post sterilization | Passed |
| Simulated Use<br>Verification of performance in claimed cycles | Passed |
| Auto-reader Maintenance of Incubation Temperature<br>Maintain 60 ± 2°C over a period of 7 days | Passed |

The results of these evaluations showed that the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, when used with the 3M™ Attest™ Auto-reader 490 or Attest™ Auto-reader 490H having software version 4.0.0 or greater, complies with ISO 11138-1:2017 and ISO 11138-3:2017, the USP requirements for biological indicators, as well as the FDA's Guidance for Biological Indicators.

The Attest™ Auto-readers were tested for safety by Underwriters Laboratory to verify compliance to:

- IEC 61010-1 (2010) 3rd Edition; Safety requirements for electrical equipment for . measurement, control, and laboratory use – Part 1: General requirements, and
- IEC 61010-2-010 (2014) 3rd Edition; Safety requirements for electrical equipment for . measurement, control, and laboratory use – Part 2-010: Particular requirements for laboratory equipment for the heating of materials

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# Summary of Clinical Testing

No clinical data was included in this premarket application submission.

| | Submission Device: | Predicate Device<br>(K121484): | Reference Device<br>(K171003): |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | 3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator<br>1492V and<br>3MTM AttestTM Auto-<br>reader 490 and 490H | 3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator<br>1492V and<br>3MTM AttestTM Auto-<br>reader 490 | 3MTM AttestTM<br>Auto-reader 490H |
| Indications for use | Use the 3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator<br>1492V in conjunction<br>with both the 3MTM<br>AttestTM Auto-reader 490<br>or the AttestTM Auto-<br>reader 490H having<br>software version 4.0.0 or<br>greater to qualify or<br>monitor dynamic-air-<br>removal steam<br>sterilization cycles of:<br>• 3 minutes at<br>270°F (132°C)<br>• 4 minutes at<br>270°F (132°C)<br>• 3 minutes at<br>275°F (135°C) | Use the 3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator<br>1492V in conjunction<br>with the 3MTM AttestTM<br>Auto-reader 490 to<br>qualify or monitor<br>dynamic-air-removal<br>(pre-vacuum) steam<br>sterilization cycles of 4<br>minutes at 270°F (132°C)<br>and 3 minutes at 275°F<br>(135°C).<br>The 3MTM AttestTM Super<br>Rapid Readout Biological<br>Indicator 1492V provides<br>a final fluorescent result<br>in 1 hour. An optional<br>visual pH color change<br>result is observed in 48<br>hours. | Use the 3MTM AttestTM Rapid<br>Readout Biological Indicator<br>1295 in conjunction with the<br>3MTM AttestTM Auto-reader<br>490H* as a standard method of<br>routine monitoring of vaporized<br>hydrogen peroxide sterilization<br>processes in the Amsco® V-<br>PRO® maX Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, and Flexible<br>cycles), and in STERRAD®<br>100S, STERRAD® NX®<br>(Standard and Advanced<br>cycles) and STERRAD®<br>100NX® (Standard, Flex,<br>Express and Duo cycles)<br>systems.<br>* Reference Device is 3MTM<br>AttestTM Auto-reader 490H<br>Only. |
| Organism | <i>Geobacillus stearothermophilus</i><br>traceable to ATCCTM<br>7953 | Identical | N/A- Reference Device is<br>3MTM AttestTM Auto-reader<br>490H Only |
| Viable spore<br>population | ≥ 1 x 106 | Identical | N/A- Reference Device is<br>3MTM AttestTM Auto-reader<br>490H Only |
| Resistance<br>characteristics | | Identical | N/A- Reference Device is<br>3MTM AttestTM Auto-reader<br>490H Only |
| • D-value<br>• Survival/Kill<br>Window | | | |
| | D-value ≥ 10 seconds at<br>132°C<br>D-value ≥ 8 seconds at<br>135°C<br>Survival Time =<br>Calculated survival time*<br>or 1 minute at 132°C and<br>40 seconds at 135°C,<br>whichever is longer | | |
| Feature | Submission Device:<br>3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator<br>1492V and<br>3MTM AttestTM Auto-<br>reader 490 and 490H | Predicate Device<br>(K121484): | Reference Device<br>(K171003):<br>3MTM AttestTM<br>Auto-reader 490H |
| | Kill Time = Calculated<br>kill time* at 132°C and at<br>135°C | | |
| Carrier material | polypropylene | Identical | N/A- Reference Device is<br>3MTM AttestTM Auto-reader<br>490H Only |
| Incubation<br>temperature | 60 ± 2°C | 56 ± 2°C | 60 ± 2°C |
| Readout time | 24 minute final<br>fluorescent result in both<br>the 490 and 490H Auto-<br>readers having software<br>version 4.0.0 or greater.<br>1 hour final fluorescent<br>result in 490 Auto-readers<br>having software versions<br>less than 4.0.0.<br>Optional visual pH color<br>change result in 48 hours | 1 hour final fluorescent<br>result in 490 Auto-<br>readers.<br>Identical | 24 minute fluorescence result<br>of 3MTM AttestTM 1295 BI read<br>in the 3MTM AttestTM Auto-<br>reader 490H. |
| Chemical indicator | Turns from pink to light<br>brown or darker upon<br>steam exposure | Identical | N/A- Reference Device is<br>3MTM AttestTM Auto-reader<br>490H Only |
| Shelf-life | 21 months | Identical | N/A- Reference Device is<br>3MTM AttestTM Auto-reader<br>490H Only |
| Design Function | Submission Device: | Reference Device: | Predicate Device |
| or | 3MTM AttestTM | (K171003) 3MTM AttestTM | (K121484): 3MTM AttestTM |
| Characteristic | Auto-reader 490 | Auto-reader 490H | Auto-reader 490 |
| Statement of<br>Intended Use | The 3MTM AttestTM 490<br>Auto-reader is designed to<br>incubate and automatically<br>read the 3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator 1492V<br>at 60°C for a final<br>fluorescent result at 24<br>minutes. | The 3MTM AttestTM 490H<br>Auto-reader is designed to<br>incubate and automatically<br>read the 3MTM AttestTM<br>Rapid Readout Biological<br>Indicator 1295 at 60°C for a<br>final fluorescent result at 24<br>minutes. | The 3MTM AttestTM 490<br>Auto-reader is designed to<br>incubate and automatically<br>read the 3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator 1492V at<br>56°C for a final fluorescent<br>result at 1 hour. |
| Incubation<br>temperature | 60 ± 2°C | Identical to Submission<br>Device | 56 ± 2°C |
| Rapid Readout<br>Capability | Yes | Identical | Identical |
| Basis of Rapid<br>Readout | Fluorescence of biological<br>medium | Identical | Identical |
| Use with<br>Biological<br>Indicators | 3MTM AttestTM Super<br>Rapid Readout Biological<br>Indicator 1492V. | 3MTM AttestTM Rapid<br>Readout Biological Indicator<br>1295. | Identical to Submission<br>Device |
| Method of<br>Fluorescence<br>Detection | UV LED, optical filters,<br>with sensing by photo<br>diode | Identical | Identical |
| Identification of<br>(+) Result | Fluorescence measurement<br>and 24 minute readout<br>algorithm | Fluorescence measurement<br>and 24 minute readout<br>algorithm | Fluorescence measurement<br>and 1 hour readout algorithm |
| Visual Indicator<br>of Adequate<br>Sterilization<br>Cycle | (-) on LCD Display | Identical | Identical |
| Visual Indicator<br>of Possible<br>Sterilization<br>Cycle Failure | (+) on LCD Display | Identical | Identical |
| Audible<br>Indicator of<br>Possible<br>Sterilization<br>Cycle Failure | Audible Alarm | Identical | Identical |
| Number of<br>Incubation Wells | 10 incubation wells/reader | Identical | Identical |
| Voltage Range | 100-240 Volts AC (12 Volt<br>DC conversion for internal<br>circuitry) | Identical | Identical |
| Calibration | No calibration.<br>Fluorescent baseline<br>measured independently<br>for each BI placed in well. | Identical | Identical |
| Design Function<br>or | Submission Device:<br>3MTM Attest™<br>Auto-reader 490 | Reference Device:<br>(K171003) 3MTM Attest™<br>Auto-reader 490H | Predicate Device<br>(K121484): 3MTM Attest™<br>Auto-reader 490 |
| Characteristic | | | |
| | Software monitors<br>incubation duration | Identical | Identical |
| | Software performs reading<br>of BI | Identical | Identical |
| System<br>Operation | Software allows user to<br>view status remotely via<br>Ethernet | Identical | Identical |
| | Software allows 100 most<br>recent results to be stored<br>electronically in the reader | Identical | Identical |
| Product Safety | UL/IEC 61010-1 | Identical | Identical |
| EMC<br>Compliance | FCC Part 15, Subpart B,<br>Class A | Identical | Identical |
| Preventative<br>Maintenance | None…